The study, which took place at two sites, consisted of 38 pediatric patients ages 2-12. The mean age was six years. Patients were randomized into two groups: one group received treatment with Elidel cream (pimecrolimus 1%), and the second group received treatment with EpiCeram. The study demonstrated that both EpiCeram and Elidel Cream produced significant improvement in patients’ conditions after four weeks of treatment.
There were no statistically significant differences between the groups treated with EpiCeram compared to those treated with Elidel Cream as measured by EASI (Eczema Area and Severity Index) scores at day 28 (the primary outcome measure). There was a statistically significant difference in median EASI score reduction at week two with the Elidel Cream group showing faster improvement at this timepoint.
Improvement in patient atopic dermatitis (AD) as measured by Investigator Global Assessment (IGA) was a secondary endpoint of the study. Both treatments demonstrated a statistically significant reduction (p<0.05) in IGA scores at weeks two and four. Itching (pruritus), a hallmark symptom of AD, was another secondary endpoint of the study. Both EpiCeram and Elidel Cream produced significant relief from itching after 28 days of treatment, and there was no statistically significant difference between the two treatments in reduction of itching at this time point. Peter Elias, chairman of Ceragenix's scientific advisory board, said: "The data from this study demonstrate that EpiCeram is effective and offers the clinician and parents of children with atopic dermatitis a new approach for treatment of this skin condition without the risks often associated with long-term use of immunosuppressants."